Skin DiseasesNCT04725292
Rare Benign Lesion of Peins
An observational study of Skin Diseases and Penile Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
PEKMB was first named and described by Lortat-Jacob \& Civatte in 1961 and by Bart \& Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Penile Diseases
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2021to 12 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: male healthy married
Who may be able to join
- 40 years
- failed medical treatment
Who cannot join
- psoriasis
- allergy
- trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt
PEKMB was first named and described by Lortat-Jacob \& Civatte in 1961 and by Bart \& Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.
- Conditions
- Skin Diseases, Penile Diseases
- Medical subject headings
- Skin Diseases, Penile Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of the skin lesion
drugs will be given to patient then the effect ,either improvement or worsening will be noticied
Measured: 1 month after treatment
improvement of associated lesion
patient complained of difficulty and burning micturition which will be seen after treatment
Measured: 1 month after drug given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start12 Jan 2021
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725292
- Sponsor's protocol ID
- penis skin lesion
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt
- ClinicalTrials.gov ID
- NCT04725292
- Acronym / sponsor ID
- penis skin lesion
- Conditions
- Skin Diseases, Penile Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PEKMB was first named and described by Lortat-Jacob \& Civatte in 1961 and by Bart \& Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- male healthy married
Key inclusion criteria (2 listed)
- 40 years
- failed medical treatment
Key exclusion criteria (3 listed)
- psoriasis
- allergy
- trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
improvement of the skin lesion
Time frame: 1 month after treatment
drugs will be given to patient then the effect ,either improvement or worsening will be noticied
improvement of associated lesion
Time frame: 1 month after drug given
patient complained of difficulty and burning micturition which will be seen after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases and Penile Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of the skin lesion (time frame: 1 month after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.